Low-Intensity Shock Wave Therapy for Refractory Overactive Bladder in Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low-Intensity Extracorporeal Shock Wave Therapy, Sham Low-Intensity Extracorporeal Shock Wave Therapy.
- Who it may be relevant to
- Registry conditions: Urinary Bladder, Overactive. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Therapeutic Effects of Low-Intensity Extracorporeal Shock Wave Therapy on Refractory Overactive Bladder Symptoms in Females
Overview
Overactive bladder is a condition characterized by a sudden and difficult-to-control need to urinate, which may occur with frequent urination, nighttime urination, and urine leakage. Some women continue to experience these symptoms despite lifestyle changes, behavioral therapy, and medication, or they cannot tolerate or decline medical treatment. This study will evaluate whether low-intensity extracorporeal shock wave therapy (Li-ESWT), a non-surgical treatment delivered externally over the lower abdomen, can safely improve refractory overactive bladder symptoms in women. A total of 40 women will be randomly assigned in equal numbers to receive either active Li-ESWT or a sham treatment. Both groups will attend one treatment session each week for six weeks. The sham procedure will be similar to the active treatment in positioning, session duration, and device sound but will not deliver shock wave energy. Symptoms will be assessed using the validated Arabic version of the 8-item Overactive Bladder Questionnaire (OAB-V8) before treatment and during follow-up. The main purpose of the study is to compare the change in OAB-V8 symptom score between the two groups after one month. Additional assessments at three months will include post-void residual urine volume, information from a 3-day voiding diary, the participant's overall impression of improvement, and any treatment-related adverse events. The study hypothesis is that Li-ESWT will improve overactive bladder symptoms and quality of life compared with sham treatment.
Interventions
- Device Low-Intensity Extracorporeal Shock Wave Therapy
Focused low-intensity extracorporeal shock wave therapy will be delivered using the PiezoWave 2 device. Each session will deliver a total of 3000 impulses at an energy density of 0.25 mJ/mm² and a frequency of 3 pulses per second. Treatment will be administered once weekly for 6 weeks. - Device Sham Low-Intensity Extracorporeal Shock Wave Therapy
A sham procedure will be administered using the same treatment setup, participant positioning, probe placement, session duration, and device sound as active therapy. A sham probe or zero-energy setting will be used so that no therapeutic shock wave energy is delivered. The procedure will be performed once weekly for 6 weeks.
Primary outcome measures
- Overactive Bladder Questionnaire 8-Item Total Score [Time frame: Baseline and 1 month after completion of the 6-week treatment]
Secondary outcome measures (6)
- Post-Void Residual Urine Volume at 3 Months [Time frame: Baseline and 3 months after completion of treatment]
- Urinary Frequency Recorded in a 3-Day Voiding Diary [Time frame: Baseline and 3 months after completion of treatment]
- Mean Voided Urine Volume Recorded in a 3-Day Voiding Diary [Time frame: Baseline and 3 months after completion of treatment]
- Urgency Level Recorded in a 3-Day Voiding Diary [Time frame: Baseline and 3 months after completion of treatment]
- Urinary Leakage Episodes Recorded in a 3-Day Voiding Diary [Time frame: Baseline and 3 months after completion of treatment]
- Functional Bladder Capacity [Time frame: Baseline and 3 months after completion of treatment]
Eligibility criteria
Inclusion criteria
- Female participants aged 18 to 70 years.
- Symptoms of overactive bladder with an Overactive Bladder Questionnaire 8-Item total score greater than 8.
- Failure of behavioral therapy and medical treatment for overactive bladder.
- Refusal of medical treatment for overactive bladder. Ability to understand the study procedures and provide written informed consent.
Exclusion criteria
- Current use of medical treatment for overactive bladder.
- Cardiac pacemaker or metallic implant in the treatment area.
- Coagulation disorder or use of anticoagulants that cannot be temporarily discontinued.
- Active urinary tract infection; participants may be reconsidered after successful treatment and recovery.
- Urinary bladder stones.
- Post-void residual urine volume greater than 100 mL.
- Lower urinary tract surgery within the previous 6 months.
- Previous pelvic radiation therapy.
- History of neuropathic disease.
- Pregnancy or planning to become pregnant.
- Hepatic, renal, or cardiac impairment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Ain Shams University Hospital — Cairo
Identifiers
NCT: NCT07739550 · FMASU MS 434/2026